RecruitingPhase 2NCT05671822

Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer

A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

258 participants

Start Date

Mar 14, 2023

Study Type

INTERVENTIONAL

Conditions

HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Summary

This is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy in HER2 expression advanced/metastatic gastric/gastroesophageal junction adenocarcinoma patients. The Phase II study was designed to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and/or immunotherapy for advanced/metastatic HER2 expression gastric/gastroesophageal conjunctional adenocarcinoma patients.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests different combinations of SHR-A1811, an antibody-drug combination (ADC) that delivers chemotherapy directly to cancer cells expressing HER2, in patients with advanced stomach or gastroesophageal junction cancer that has the HER2 protein on its cells. **You may be eligible if...** - You are 18–75 years old - You have advanced or metastatic stomach or gastroesophageal junction cancer confirmed by biopsy - Your tumor tests positive for HER2 - You are in good physical condition (ECOG 0–1) with an expected survival of at least 3 months - You have either failed prior treatments or are newly diagnosed (depending on the study phase) **You may NOT be eligible if...** - You have fluid buildup in the chest, abdomen, or around the heart that needs treatment - You have severe organ dysfunction or uncontrolled infections - Your cancer has spread to the brain with untreated metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-A1811 and SHR-1701

(Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion;

DRUGSHR-A1811 and capecitabine

(Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；

DRUGSHR-A181, SHR-1701, and capecitabine

(Arm 1C) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion Drug：capecitabine, administered orally；

DRUGSHR-A1811, SHR-1316, and capecitabine

(Arm 1D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally；

DRUGSHR-A1811, SHR-1316, capecitabine,and oxaliplatin

(Arm 1F) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion

DRUGSHR-A1811, SHR-1316, and 5-FU

(Arm 1G) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion

DRUGSHR-A1811, SHR-1316, and capecitabine

(Arm 2A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316 administered as an IV infusion; Drug：capecitabine, administered orally；

DRUGSHR-1316 and SHR-A1811

(Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion

DRUGSHR-A1811 and capecitabine

(Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；

DRUGSHR-A1811, SHR-1316, and 5-FU

(Arm 2D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion

DRUGSHR-A1811and 5-FU

(Arm 2E) Drug: SHR-A1811, administered as an IV infusion Drug：5-FU，administered as an IV infusion

DRUGSHR-A1811, SHR-1316, capecitabine,and oxaliplatin

(Arm 2F) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion

Locations(1)

Zhongshan Hospital, FuDan University

Shanghai, Shanghai Municipality, China

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NCT05671822